Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With Nateglinide in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Nateglinide Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- change from baseline in hemoglobin A1c (HbA1c)
研究概览
简要总结
This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.
详细描述
This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on Nateglinide alone more than 4 weeks. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients receiving with Nateglinide mono-therapy for at least 4 weeks
- •HbA1c value between 6.5 and 9.5%
- •Body Mass Index (BMI) 20.0 - 45.0 kg/m2
排除标准
- •Type 1 diabetes mellitus patients
- •Serum creatinine > upper limit of normal
- •Proteinuria (albumin/creatinine ratio > 300mg/g)
- •Dysuria and/or urinary tract infection, genital infection
- •Significant renal, hepatic or cardiovascular diseases
- •Severe gastrointestinal diseases
研究组 & 干预措施
ASP group
Concomitant administration of ASP1941 and nateglinide
干预措施: ipragliflozin (Drug)
ASP group
Concomitant administration of ASP1941 and nateglinide
干预措施: nateglinide (Drug)
结局指标
主要结局
change from baseline in hemoglobin A1c (HbA1c)
时间窗: baseline and for 24 weeks
次要结局
- Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)(for 52 weeks)
- change from baseline in fasting plasma glucose(baseline and for 24 weeks)
- change from baseline in fasting serum insulin(baseline and for 24 weeks)